Status:
COMPLETED
Dasatinib and Lapatinib Ditolsylate in Treating Patients With Advanced Solid Tumors That Cannot Be Removed By Surgery
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Dasatinib and lapatinib ditoslylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and ...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose of dasatinib combined with lapatinib. II. To describe the toxicities associated with this treatment combination. III. To assess the p...
Eligibility Criteria
Inclusion
- Histologic proof of cancer that is now unresectable and refractory to or refused all standard treatment for the disease
- Please contact study investigator and/or consult protocol document for specific details on laboratory criteria
- Ability to provide informed consent
- Willingness to return to Mayo Clinic for follow up
- Life expectancy \>= 12 weeks
- Negative serum pregnancy test done =\< 7 days prior to registration for women of childbearing potential only
- Echocardiogram with ejection fraction \> 50%
- ECOG performance status (PS) 0-2
- Able to swallow pills whole (patients with feeding tubes may be eligible if whole pills can be taken and tolerated through the feeding tube)
- Willingness to provide the biologic specimens as required by the protocol for Cohort II, (MTD) patients only
Exclusion
- Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
- Pregnant women
- Any of the following prior therapies: chemotherapy =\< 4 weeks prior to registration; mitomycin C/nitrosoureas =\< 6 weeks prior to registration; immunotherapy =\< 4 weeks prior to registration; biologic therapy =\< 4 weeks prior to registration
- Patients who have been treated with Avastin, Herceptin, or Erbitux are eligible if last treatment is \>= 4 weeks; molecularly targeted agents (erlotinib, sunitinib, sorafenib, gefitinib, imatinib) =\< 4 weeks prior to registration; radiation therapy =\< 4 weeks prior to registration; radiation to \> 25% of bone marrow
- CNS metastases that are not stable for at least 4 weeks prior to registration based on imaging, clinical assessment, and use of steroids
- Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the study and until 4 weeks following study
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation)
- Current therapy with a CYP3A4 inhibitor or inducer
- Known standard therapy for the patient's disease that is not refractory to treatment that is potentially curative or definitely capable of extending life expectancy
- Uncontrolled pleural or pericardial effusion of any grade
- Uncontrolled angina, congestive heart failure or MI within 6 months prior to registration
- Diagnosed congenital long QT syndrome
- Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
- Prolonged QTc interval on pre-entry electrocardiogram (\> 450 msec)
- Subjects with potassium or magnesium that are not within normal limits and cannot be corrected prior to registration
- New York Heart Association classification III or IV
- Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
- Ongoing or recent (=\< 3 months prior to registration) significant gastrointestinal bleeding
- Prophylactic use of colony-stimulating factors during the study is not allowed
- Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
- G.I conditions that may interfere with drug absorption such as Ulcerative Colitis, Crohn's Disease, and Short Bowel Syndrome
- Active hepatic or biliary disease (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator's assessment)
- Nursing women
- Uncontrolled infection
- Seizure disorder
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2014
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00662636
Start Date
August 1 2008
End Date
December 18 2014
Last Update
March 23 2017
Active Locations (3)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
3
Mayo Clinic
Rochester, Minnesota, United States, 55905